Sorafenib, Cisplatin, and Etoposide in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Afshin Dowlati, MD

Status and phase

Terminated

Phase 2

Conditions

Lung Cancer

Treatments

Drug: etoposide

Drug: sorafenib tosylate

Drug: cisplatin

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00726986

CASE8507 (Other Identifier)

P30CA043703 (U.S. NIH Grant/Contract)

CASE-8507-CC486 (Other Identifier)

Details and patient eligibility

About

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving sorafenib together with cisplatin and etoposide works in treating patients with extensive-stage small cell lung cancer.

Full description

OBJECTIVES:

To evaluate the 1-year progression-free survival of patients with extensive-stage small cell lung cancer treated with sorafenib tosylate in combination with cisplatin and etoposide.
To evaluate the 1-year overall survival and response rate in these patients.
To evaluate the safety of these drugs in these patients.

OUTLINE: This is a multicenter study.

Patients receive cisplatin IV over 30-60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral sorafenib tosylate twice daily beginning on day 1 of course 1 and continuing for up to 1 year in the absence of disease progression or unacceptable toxicity.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Diagnosis of extensive-stage small cell lung cancer
No untreated brain metastases
- No active symptoms related to brain metastases

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Hemoglobin ≥ 9.0 g/dL
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement)
Creatinine ≤ 1.5 times ULN
INR < 1.5 or PT/PTT normal
No history of cardiac disease, including any of the following:
- NYHA class III-IV congestive heart failure
- Unstable angina (i.e., anginal symptoms at rest)
- Onset of angina within the past 3 months
- Myocardial infarction within the past 6 months
No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
No uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg, despite optimal medical management
No thrombolic or embolic events, such as cerebrovascular accident or transient ischemic attacks, within the past 6 months
No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within the past 4 weeks
No other hemorrhage/bleeding event ≥ CTCAE grade 3 within the past 4 weeks
No known HIV infection or chronic hepatitis B or C infection
No active clinically serious infection > CTCAE grade 2
No serious non-healing wound, ulcer, or bone fracture
No evidence or history of bleeding diathesis or coagulopathy
No significant traumatic injury within the past 4 weeks
No known or suspected allergy to sorafenib tosylate or to any other drug given during the study
No condition that would impair the patient's ability to swallow whole pills
No known malabsorption problem
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception
- Male patients must use effective contraception during and for ≥ 3 months after completion of sorafenib tosylate